| Primary Device ID | 00841732104822 |
| NIH Device Record Key | 5b554e47-1776-4c04-a6e9-3ef071ec2bb5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RENOIR Posterior Cervico-Thoracic Fixation System |
| Version Model Number | 012.7051 |
| Company DUNS | 080138504 |
| Company Name | CTL MEDICAL CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841732104822 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841732104822]
Moist Heat or Steam Sterilization
[00841732104822]
Moist Heat or Steam Sterilization
[00841732104822]
Moist Heat or Steam Sterilization
[00841732104822]
Moist Heat or Steam Sterilization
[00841732104822]
Moist Heat or Steam Sterilization
[00841732104822]
Moist Heat or Steam Sterilization
[00841732104822]
Moist Heat or Steam Sterilization
[00841732104822]
Moist Heat or Steam Sterilization
[00841732104822]
Moist Heat or Steam Sterilization
[00841732104822]
Moist Heat or Steam Sterilization
[00841732104822]
Moist Heat or Steam Sterilization
[00841732104822]
Moist Heat or Steam Sterilization
[00841732104822]
Moist Heat or Steam Sterilization
[00841732104822]
Moist Heat or Steam Sterilization
[00841732104822]
Moist Heat or Steam Sterilization
[00841732104822]
Moist Heat or Steam Sterilization
[00841732104822]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-03-05 |
| 00841732105010 | Hex Socket Driver, 6.0 |
| 00841732105003 | Counter Torque, Cross Connector |
| 00841732104983 | Reduction Screwhead Cutter |
| 00841732104976 | Distractor |
| 00841732104952 | Anti-Torque Tool |
| 00841732104945 | Driver, Torque Limiter, 3 N-m |
| 00841732104938 | Driver, Set Screw, Star |
| 00841732104921 | Rod Rocker Arm |
| 00841732104914 | Rod Persuader |
| 00841732104907 | Rod Pusher |
| 00841732104891 | Rod Bender, In-Situ, RH, D3.5 |
| 00841732104884 | Rod Bender, In-Situ, LH, D3.5 |
| 00841732104877 | Rod Bender, In-Situ, RH, D4.5 |
| 00841732104860 | Rod Bender, In-Situ, LH, D4.5 |
| 00841732104853 | Rod Bender |
| 00841732104846 | Rod Cutter |
| 00841732104822 | Alignment Tool / Rod Pusher |
| 00841732104815 | Driver, Screw |
| 00841732104808 | Driver, Reduction Screw |
| 00841732104792 | Driver, Polyaxial Screw |
| 00841732104785 | Tester, Curved |
| 00841732104778 | Tester, Straight |
| 00841732104747 | Depth Gauge |
| 00841732104730 | Tap, 3.0 x L14 |
| 00841732104723 | Tap, 3.0 x L12 |
| 00841732104716 | Tap, 3.0 x L10 |
| 00841732104693 | Drill, D2.6 x L10mm |
| 00841732104686 | Drill, D2.6 x L14mm |
| 00841732104679 | Drill, D2.6 x L12mm |
| 00841732104648 | Straight Handle, Trilobe QC |
| 00841732104631 | Angled Hook(left), L17mm |
| 00841732104624 | Angled Hook(Right), L17mm |
| 00841732104617 | Lamina Hook, L16mm |
| 00841732104600 | RENOIR™ Polyaxial Screw, 4.0 x L24mm |
| 00841732104594 | RENOIR™ Polyaxial Screw, 4.0 x L22mm |
| 00841732104587 | RENOIR™ Polyaxial Screw, 4.0 x L20mm |
| 00841732104570 | RENOIR™ Polyaxial Screw, 4.0 x L18mm |
| 00841732104563 | RENOIR™ Polyaxial Screw, 4.0 x L16mm |
| 00841732104556 | RENOIR™ Polyaxial Screw, 4.0 x L14mm |
| 00841732104549 | RENOIR™ Polyaxial Screw, 4.0 x L12mm |
| 00841732104532 | RENOIR™ Polyaxial Screw, 4.0 x L10mm |
| 00841732104525 | RENOIR™ Polyaxial Screw, 3.5 x L22mm |
| 00841732104518 | RENOIR™ Polyaxial Screw, 3.5 x L20mm |
| 00841732104501 | RENOIR™ Polyaxial Screw, 3.5 x L18mm |
| 00841732104495 | RENOIR™ Polyaxial Screw, 3.5 x L16mm |
| 00841732104488 | RENOIR™ Polyaxial Screw, 3.5 x 14mm |
| 00841732104471 | RENOIR™ Polyaxial Screw, 3.5 x 12mm |
| 00841732104464 | RENOIR™ Polyaxial Screw, 3.5 x 10mm |
| 00841732104457 | RENOIR™ Polyaxial Screw, 3.5 x 8mm |
| 00841732104440 | Set Screw, Cap Head, Star, OD7 x L3.5mm |